Medtech
Products
Mooni NG-5
Powder Free Exam Gloves. Also Provides Safe Conctact with Food.
Mooni NG-5 Blue is a powder-free, non-sterile medical examination glove (Class I), designed for single use.
It is also suitable for handling fatty and aqueous foods.
• CE Declaration of Conformity
• Mooni EU Declaration of Conformity
EU Regulation 2016/425 and MDD 93/42/EEG:
• EN 455-1-2-3
• EN 420
• EN 16523-1:2015
• EN 374-1:2016
• EN ISO 374-2
• EN ISO 374-5
• EN 388:2016
Products to be used with foods
• EN 1186 (aqueous and fatty foodstuffs)
US Test Reports
• ASTM D6319
• US FDA 21 CFR 177.26000
Colors
Declarations
• Declaration of Compliance
• Declaration of Conformity PPE
• Declaration of Conformity Medical
Mooni NG-5
Powder Free Exam Gloves. Also Provides Safe Conctact with Food.
Mooni NG-5 Blue is a powder-free, non-sterile medical examination glove (Class I), designed for single use.
It is also suitable for handling fatty and aqueous foods.
• CE Declaration of Conformity
• Mooni EU Declaration of Conformity
EU Regulation 2016/425 and MDD 93/42/EEG:
• EN 455-1-2-3
• EN 420
• EN 16523-1:2015
• EN 374-1:2016
• EN ISO 374-2
• EN ISO 374-5
• EN 388:2016
Products to be used with foods
• EN 1186 (aqueous and fatty foodstuffs)
US Test Reports
• ASTM D6319
• US FDA 21 CFR 177.26000
Colors
Declarations
• Declaration of Compliance
• Declaration of Conformity PPE
• Declaration of Conformity Medical
Mooni VG-5
Powder Free Vinyl exam Gloves.
Mooni VG-5 is a powder-free, non-sterile examination glove, designed for single use.
It is manufactured with a latex-free formula without natural rubber protein and does not contain Carbamates, Thiazoloes and Thiurams.
• CE Declaration of Conformity
• Mooni EU Declaration of Conformity
EU Test Reports:
• EN 455
• EN 374
US Test Reports
• ASTM D5250
Mooni LG-5
Powder Free Latex exam Gloves.
Mooni LG-5 is a powder-free, non-sterile examination glove, designed for single use.
It is biodegradeable and environmentally friendly. With excellent fit, comfort and soft to the touch. Micro textured surface for secure grip.
• CE Declaration of Conformity
• Mooni EU Declaration of Conformity
EU Test Reports:
• EN 455-1-2-3
• EN 16523-1 (EN 374-3)
• EN 374-4
Mooni SG-5
Sterile Rugger Surgical Gloves.
Mooni SG-5 is a sterile surgical glove, designed for single use. They are available with or without powder.
It is made of natural rubber latex from Thailand and is non-hazardous.
• CE Declaration of Conformity
• Mooni EU Declaration of Conformity
EU Test Reports:
• EN 455-1-2-3-5
• MDD93/42/EEC Annex V
US Test Reports:
• 510(k)
• ASTM D3577
EasyDiagnosis COVID-19 (SARS-CoV-2) Antigen Test
Antigen Test
- Fast: The result is available in 15 minutes
- Easy: Easy to collect samples and easy to read result
- Early: Identify acute or early infection
- Convenient: No instrument
- Efficient: Suitable for large-scale rapid
Recognizes the Omicron variant - 3-in-1 Flexible Sampling: Anterior, Nasal or Nasopharyngeal
EasyDiagnosis COVID-19 (SARS-CoV-2) Antigen Test Kit is intended for in vitro qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19. The kit is suitable for layperson use, children under age of 14 should be assisted by an adult. Please always seek for assistance and supervision with the test when needed and follow your local guidelines for specimen collection by children. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
EasyDiagnosis COVID-19 (SARS-CoV-2) Antigen Test Kit comes in 2 versions:
- A-1, Nonprefilled (EST, EN, DK, NO, SE)
- B-1, Prefilled (EN, DE, FR, IT, ES)
Certifications & Standards
ISO 45001:2018
ISO 14001:2015
EN ISO 13485:2016
EC Declaration of Conformity
CE IVDD-NB Certificate For Self-Test CE Declaration of Comformity
Wuhan EasyDiagnosis Biomedicine Co., Ltd.
